Clinical trial • Phase IV • Musculoskeletal

METHOTREXATE for Rheumatoid arthritis

Phase IV trial of METHOTREXATE for Rheumatoid arthritis.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Rheumatoid arthritis
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
03-06-2024
First CTIS Authorization Date
03-07-2024

Trial design

Randomised, randomised comparison of per oral methotrexate versus subcutaneous methotrexate; dosing described as rheumatoid arthritis treatment 5-30 mg once weekly (route: oral tablet vs subcutaneous injection).-controlled Phase IV trial across 9 sites in Sweden.

Randomised
Yes
Comparator
Randomised comparison of per oral methotrexate versus subcutaneous methotrexate; dosing described as Rheumatoid Arthritis treatment 5-30 mg once weekly (route: oral tablet vs subcutaneous injection).
Target Sample Size
212
Trial Duration For Participant
730

Eligibility

Recruits 212 No vulnerable populations selected. Adults only (18-95 years). Written informed consent required from each participant. Exclusion includes "Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation or inability to answer questionnaire in written Swedish", indicating participants must be able to understand Swedish and provide written consent; no assent process described..

Pregnancy Exclusion
Anamnestic information on pregnancy, breastfeeding, or planned pregnancy
Vulnerable Population
No vulnerable populations selected. Adults only (18-95 years). Written informed consent required from each participant. Exclusion includes "Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation or inability to answer questionnaire in written Swedish", indicating participants must be able to understand Swedish and provide written consent; no assent process described.

Inclusion criteria

  • {"criterion_text":"- The subject has given written consent to participate in the study\n- Diagnosis of rheumatoid arthritis by rheumatologist fulfilling 2010 Rheumatoid Arthritis Classification Criteria\n- Indication of methotrexate\n- 18-95 years of age\n- Women of Childbearing Capacity (WOCBC) must: a) Comply to use of highly effective contraception methods during the course of the trial. b) Have a negative pregnancy test.\n- Male patients included in the study that have fertile female partners must use adequate contraception within their relationship during the same period of time"}

Exclusion criteria

  • {"criterion_text":"- Contraindications for methotrexate\n- Previous treatment with any DMARD within the last five years\n- Known or suspected allergies against methotrexate or any other substance in the given medication\n- Anamnestic information on pregnancy, breastfeeding, or planned pregnancy\n- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation or inability to answer questionnaire in written Swedish\n- Treatment or disease which, according to the investigator, can affect treatment or study results.\n- Fear of needles leading to not being able to use subcutaneous injections\n- For the study in gut microbiota: Use of antibiotics or probiotics within the last 3 months"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- DAS28","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Number of swollen joints\n- Number of tender joints\n- HAQ\n- VAS pain\n- VAS general health\n- VAS fatigue\n- Doctor's global assessment\n- Number of individuals remaining on the designated drug (drug retention) including number of individuals prescribed biologic treatment\n- Number of patient´s contact with any health care giver\n- All other medications, including corticosteroids, other csDMARDs, biologics, intraarticular injections as well as change in dosage or administration route of methotrexate\n- ESR\n- CRP\n- Number of AE\n- Patients preferences\n- EQ5D\n- Gutmicrobiota\n- Questions on diet and alcohol consumption","definition_or_measurement_approach":""}

Recruitment

Registry Or Advocacy Recruitment
Yes
Planned Sample Size
212
Recruitment Window Months
56
Consent Approach
Written informed consent required from each participant ("The subject has given written consent to participate in the study"). Participants are adults (18-95 years); no assent process described. Questionnaires must be answered in written Swedish and individuals with language difficulties are excluded, indicating consent materials/questionnaires are in Swedish. A subject information and informed consent form document is listed ("Forskningspersonsinformation MTXRA").

Methods

  • Register-based recruitment (described in the title as a "randomised register based multicentre study") using rheumatology clinical/registry networks in Sweden.

Geography

Total Number Of Sites
9
Total Number Of Participants
212

Sweden

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
17-03-2025
Processing Time Days
273
Number Of Sites
9
Number Of Participants
212

Sites

Site Name
Region Vaesternorrland
Department Name
Reumatologisk klinik
Contact Person Name
John Svensson
Contact Person Email
john.svensson@rvn.se
Site Name
Region Vaestmanland
Department Name
Reumatologisk klinik, Västerås sjukhus
Contact Person Name
My Axelhed
Site Name
Region Stockholm – SLSO
Department Name
Centrum för reumatologi
Contact Person Name
Lotta Ljung
Contact Person Email
lotta.ljung@sll.se
Site Name
Region Oerebro Laen
Department Name
Reumatologsektionen
Contact Person Name
Annika Söderbergh
Site Name
Region Dalarna
Department Name
Reumatolgiska kliniken
Contact Person Name
Tomas Husmark
Contact Person Email
tomas.husmark@regiondalarna.se
Site Name
Malarsjukhuset Eskilstuna
Department Name
Reumatolgisk klinik, Region Sörmland
Contact Person Name
Mitra Linnerud Keshavarz
Site Name
Region Gaevleborg
Department Name
Reumatologisk klinik, Gävle sjukhus
Contact Person Name
Silvia Quattrino
Site Name
Skaraborg Hospital-Vastra Gotalandsregionen
Department Name
Reumatologmottagningen
Contact Person Name
Daniel Glinatsi
Contact Person Email
daniel.glinatsi@vgregion.se
Site Name
Region Vaesterbotten
Department Name
Reumatologiska kliniken
Contact Person Name
Anna Södergren
Contact Person Email
anna.sodergren@umu.se

Sponsor

Primary sponsor

Full Name
Region Vaesterbotten
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
METHOTREXATE (TABLET)
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Frequency
once weekly
Maximum Dose
30 mg once weekly
Investigational Product Name
METHOTREXATE (SOLUTION FOR INJECTION)
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS
Frequency
once weekly
Maximum Dose
30 mg once weekly

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